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<ep-patent-document id="EP97308882B1" file="EP97308882NWB1.xml" lang="en" country="EP" doc-number="0841576" kind="B1" date-publ="20040407" status="n" dtd-version="ep-patent-document-v1-1">
<SDOBI lang="en"><B000><eptags><B001EP>......DE....FR..........NL......................................................</B001EP><B005EP>J</B005EP><B007EP>DIM350 (Ver 2.1 Jan 2001)
 2100000/0</B007EP></eptags></B000><B100><B110>0841576</B110><B120><B121>EUROPEAN PATENT SPECIFICATION</B121></B120><B130>B1</B130><B140><date>20040407</date></B140><B190>EP</B190></B100><B200><B210>97308882.6</B210><B220><date>19971105</date></B220><B240><B241><date>19981105</date></B241><B242><date>20021030</date></B242></B240><B250>en</B250><B251EP>en</B251EP><B260>en</B260></B200><B300><B310>9623664</B310><B320><date>19961112</date></B320><B330><ctry>GB</ctry></B330><B310>9704883</B310><B320><date>19970310</date></B320><B330><ctry>GB</ctry></B330></B300><B400><B405><date>20040407</date><bnum>200415</bnum></B405><B430><date>19980513</date><bnum>199820</bnum></B430><B450><date>20040407</date><bnum>200415</bnum></B450></B400><B500><B510><B516>7</B516><B511> 7G 01R  33/34   A</B511></B510><B540><B541>de</B541><B542>Gerät für die magnetische Kernresonanz</B542><B541>en</B541><B542>Nuclear magnetic resonance apparatus</B542><B541>fr</B541><B542>Appareil de résonance magnétique nucléaire</B542></B540><B560><B561><text>EP-A- 0 558 029</text></B561><B561><text>EP-A- 0 627 206</text></B561><B561><text>WO-A-93/08733</text></B561><B561><text>US-A- 5 188 111</text></B561></B560><B590><B598>1</B598></B590></B500><B700><B720><B721><snm>Young, Ian Robert</snm><adr><str>Church Hill Cottage,
West Overton</str><city>Nr. Marlborough,
Wiltshire SN8 4ER</city><ctry>GB</ctry></adr></B721></B720><B730><B731><snm>Philips Medical Systems (Cleveland), Inc.</snm><iid>03997830</iid><irf>P/60993/PKR</irf><adr><str>595 Miner Road</str><city>Cleveland, Ohio 44143</city><ctry>US</ctry></adr></B731></B730><B740><B741><snm>van der Veer, Johannis Leendert</snm><sfx>et al</sfx><iid>00078072</iid><adr><str>Philips
Intellectual Property &amp; Standards
P.O. Box 220</str><city>5600 AE  Eindhoven</city><ctry>NL</ctry></adr></B741></B740></B700><B800><B840><ctry>DE</ctry><ctry>FR</ctry><ctry>NL</ctry></B840></B800></SDOBI><!-- EPO <DP n="1"> -->
<description id="desc" lang="en">
<p id="p0001" num="0001">The invention relates to a probe for use with magnetic resonance imaging apparatus, which probe is designed to be inserted into and removed from a patient and which comprises a former upon which an r.f. coil is mounted.</p>
<p id="p0002" num="0002">The invention also relates to a method of calibrating an externally generated beam of energy where such a probe is used in an interventional procedure on a patient.</p>
<p id="p0003" num="0003">Inserted or implanted NMR coils can be sited in many cases close to a lesion which it is proposed to treat by the application of an external therapy remotely targeted at the lesion. Many interventional therapies are thermal in nature, and involve energies which are intentionally destructive of tissue locally. Such therapies include r.f. hyperthermia, laser ablation and focussed ultrasound. These therapies depend on assumptions about tissue properties in assessing their exact energy profiles, and the location of the focus, or principal region of heat deposition. Because of uncertainties in in vivo temparture measurement, pilot energy depositions are not a satisfactory method of determining energy patterns in human subjects. It is possible to estimate spot location from external data but, short of heating up a region to see where it is, it is difficult to be sure it is where it was intended to be. Reflection, refraction and scattering can affect its location significantly. Heating hot enough to be seen reliably with MRI means that tissue is damaged, so that if there were an error in location, normal tissue might be unintentionally destroyed.</p>
<p id="p0004" num="0004">In EP-A-0 558 029 it has been proposed to provide a probe containing an MRI coil with temperature and intensity sensors on the outside of a bulb which can be blown up around the probe to rest against the tissue outside. Then the maximum values of the temperature and intensity measured during ultrasonic wave treatment are compared with values calculated for the treatment, with a view to minimising the differences. However, the temperature and intensity sensors will measure the temperature and intensity adjacent them, but this is only indicative of the temperature and intensity at the intended focus of heat deposition, because temperature and intensity gradients are large and variable.</p>
<p id="p0005" num="0005">It is an object of the present invention to provide a probe and a method of the kinds mentioned in the opening paragraphs by means of which the aforementioned problem is alleviated.<!-- EPO <DP n="2"> --></p>
<p id="p0006" num="0006">In order to achieve this object, a probe in accordance with the invention is characterized in that the former also carries at least one transducer or sensor in a fixed relationship to said r.f. coil in order to control the target of energy relating to an interventional procedure both as to position and strength.</p>
<p id="p0007" num="0007">In order to achieve this object a method in accordance with the inventiqn is characterized in that it comprises the steps of inserting into the patient a probe comprising a former and an r.f. coil mounted on the former for use with magnetic resonance imaging apparatus, steering the beam at a power at which damage to tissue is not possible to at least one transducer or sensor in the probe, and comparing the actual location of the transducer derived from the magnetic resonance imaging apparatus with the indicated location derived from control apparatus for the externally generated beam of energy.</p>
<p id="p0008" num="0008">The targeting of energy in the treatment itself will then be improved. The method suggested here is particularly relevant to r.f. hyperthermia and focussed ultrasound. In both of these the exact distribution of energy inside the relevant tissue is important but hard to determine.</p>
<p id="p0009" num="0009">If internal coils (of those for the anus, tectum etc.) are used to obtain better quality images of internal structures during therapy, the coil formers can be used to locate transducers which can detect the particular radiation at low intensity (well below the level needed to damage tissue). The beams of the energy source can then be steered to target the transducers, which can easily be sensitive enough to avoid any extensible heating of local tissues, and so to establish the beam characteristics of the radiation source near to the target region. The location of the coil in the tissue can be determined from images. If the location of the transducers in the coil former is known, then the shape and size of the beam can be determined as the transducers of the therapy source are adjusted.</p>
<p id="p0010" num="0010">Conveniently, more than one transducer can be distributed around the NMR coil to provide a swifter means of detecting beam shape and size if it is not very well localized, as in the case of r.f. hyperthermia, and to help by providing additional information<!-- EPO <DP n="3"> --> for triangulation to provide a better measure of the effective location of the beam relative to the transducers. This will assist in working out any movements necessary to adjust the therapy sources to locate on its target accurately. Multiple sensors are advantageous if the coil is large enough (e.g. with a prostate coil monitoring ablation of a prostate, where three is a useful number), allowing greater interrogation of beam profiles, and better discrimination of its behaviour when being steered.</p>
<p id="p0011" num="0011">For focussed ultrasound (ultrasonic ablation) PLZT (lead lanthanum zirconate titanate) piezoelectric transducers can be used as they are directly compatible with MR. Multiple dipoles (appropriately tuned coils) can be used for r.f. hyperthermia (looking at the E-field rather than the H-field, though the latter can be monitored also).</p>
<p id="p0012" num="0012">A probe for use with magnetic resonance imaging apparatus, and a method using the probe, in accordance with the invention, will now be described, by way of example, with reference to the accompanying figure, which is a perspective view, partly cut away, of the probe.</p>
<p id="p0013" num="0013">The probe indicated generally by the reference numeral 1 is suitable for rectal insertion and may be used, for example, for imaging the prostate. The probe consists of a solid former 2 which bears an approximately rectangular r.f. coil 3 which includes a tuning capacitor 4 and leads 5 which connect down the handle of the probe, which is partly cut away, to processing electronics which are not shown.<!-- EPO <DP n="4"> --></p>
<p id="p0014" num="0014">The probe is used in conjunction with magnetic resonance imaging apparatus not shown, in which a main magnetic field is set up through the patient, and an r.f. pulse is applied through a coil or coils to re-orientate protons aligned with the field. The r.f. pulse may be applied from separate coils or from the coil 3 in the probe 1. The resulting relaxation process in which the protons re-orientate causes a magnetic flux through the coil 3 which produces a current in it which is measured by the processing electronics. The measured signal is spatially encoded by means of gradients in the main magnetic field.</p>
<p id="p0015" num="0015">The invention is particularly concerned with applications in which tissue is being treated by the application of an external energy source targeted at the tissue, in order, for example, to destroy diseased tissue. For example, the external energy source could comprise a focussed ultrasound system.</p>
<p id="p0016" num="0016">Having identified the diseased region from the MR image, suitable data can be fed into the control system for the externally mounted focussed ultrasound system, in order to generate a size, shape and location of focal spot which corresponds to the region it is intended to destroy thermally. However, it has been found that the actual location of the focal spot will not necessarily be the same as that set into the control system.</p>
<p id="p0017" num="0017">In accordance with the invention, the former 2 of the probe 1 carries at least one transducer (in fact, four) 6-9 which can detect the beam of ultrasound.<!-- EPO <DP n="5"> --></p>
<p id="p0018" num="0018">Thus, the ultrasound system is turned to a low setting at which damage to tissue is not possible, and the beam is steered until the transducer 6-9 (which are connected to the processing electronics via connections in the handle of the probe) indicate that the beam is focussed on the probe. The indicated position of the focal spot as read from the control system for the ultrasound can now be compared with the actual position of the focal spot, as determined from the magnetic resonance image (MRI), and appropriate corrections can be made to the control system for the ultrasound image, in order to calibrate the latter.</p>
<p id="p0019" num="0019">Then when the treatment takes place, at the operational intensity, the beam will be more accurately directed to the desired area than hitherto.</p>
<p id="p0020" num="0020">The transducers may be piezoelectric (for example PLZT transducers). However, the transducers could be replaced by sensors to detect heat, for example, infra-red sensors connected to optical fibres extending down the handle of the probe, which would give a measure of temperature, or temperature transducers such as thermocouples could be used. This would apply whether the treatment was focussed ultrasound, laser ablation, or r.f. hyperthermia.</p>
<p id="p0021" num="0021">For laser ablation treatment, an infra-red sensor could be used to sense local necrotisation by reference to local tissue oxygenation. This could be sensed by sensing the relative amounts of haemoglobin and de-oxyhaemoglobin. The latter have absorption edges in the near infra-red which are displaced relative to each other.<!-- EPO <DP n="6"> --></p>
<p id="p0022" num="0022">Multiple wavelengths of infra-red may be transmitted through the tissue to enable the relative quantification of the two. Typically a single detector is used to detect two or three wavelengths transmitted from individual laser light sources alternately.</p>
<p id="p0023" num="0023">For r.f. hyperthermia treatment, dipoles could be used to detect the externally applied field at the probe.</p>
<p id="p0024" num="0024">A combination of photo-detectors, piezoelectric sensors and dipoles could be employed.</p>
<p id="p0025" num="0025">Fiducial markers (objects such as water containing balls which would show up well on the magnetic resonance image) could be used to improve the accuracy of the location of the coil on the magnetic resonance image. A fiducial marker could be located on the former on the coil axis, and the coil could be modelled around the fiducial on the magnetic resonance image. If the coil is surrounded by tissue giving an RR signal (a cardiac signal) which happens quite a lot, the coil itself will show up on the magnetic resonance image and fiducial markers will not be necessary.</p>
<p id="p0026" num="0026">While the illustrated probe is suitable for rectal insertion for imaging the prostate, the invention is not limited to rectal probes, and is applicable to probes to be inserted and removed from other passages in the human or animal body.</p>
</description><!-- EPO <DP n="7"> -->
<claims id="claims01" lang="en">
<claim id="c-en-01-0001" num="0001">
<claim-text>A probe (1) for use with magnetic resonance imaging apparatus, which probe is designed to be inserted into and removed from a patient and which comprises a former (2) upon which an r.f. coil (3) is mounted, <b>characterized in that</b> the former (2) also carries at least one transducer or sensor (6, 7, 8, 9) in a fixed relationship to said r.f. coil in order to control the target of energy relating to an interventional procedure both as to position and strength.</claim-text></claim>
<claim id="c-en-01-0002" num="0002">
<claim-text>A probe (1) as claimed in claim 1, <b>characterized in that</b> the former (2) carries at least two transducers or sensors (6, 7 ,8 ,9) in a fixed relationship to said r.f. coil in order to control the target of energy relating to an interventional procedure both as to position and strength.</claim-text></claim>
<claim id="c-en-01-0003" num="0003">
<claim-text>A probe (1) as claimed in claim 1 or 2 for use with interventional ultrasound ablation, <b>characterized in that</b> at least one of the transducers or sensors (6, 7 ,8 ,9) is a piezoelectric transducer.</claim-text></claim>
<claim id="c-en-01-0004" num="0004">
<claim-text>A probe (1) as claimed in claim 3, <b>characterized in that</b> the piezoelectric transducer is a PLZT transducer.</claim-text></claim>
<claim id="c-en-01-0005" num="0005">
<claim-text>A probe (1) as claimed in claim 1 or 2, <b>characterized in that</b> at least one of the sensors (6, 7 ,8 ,9) is an infra-red sensor.</claim-text></claim>
<claim id="c-en-01-0006" num="0006">
<claim-text>A method of calibrating an externally generated beam of energy to be used in an interventional procedure on a patient, comprising the steps of inserting into the patient a probe (1) according to claim 1 comprising a former (2) and an r.f. coil (3) mounted on the former (2) for use with magnetic resonance imaging apparatus, steering the beam at a power at which damage to tissue is not possible to at least one transducer or sensor (6, 7 ,8 ,9) in the probe (1), and comparing the actual location of the transducer derived from the magnetic resonance imaging apparatus with the indicated location derived from control apparatus for the externally generated beam of energy.<!-- EPO <DP n="8"> --></claim-text></claim>
<claim id="c-en-01-0007" num="0007">
<claim-text>A method as claimed in claim 6, <b>characterized in that</b> the transducer or sensor (6, 7 ,8 ,9) responds to ultrasonic vibrations.</claim-text></claim>
</claims><!-- EPO <DP n="9"> -->
<claims id="claims02" lang="de">
<claim id="c-de-01-0001" num="0001">
<claim-text>Sonde (1) zur Verwendung in Verbindung mit einem Gerät für die magnetische Kernresonanz, wobei die Sonde so konzipiert ist, dass sie in den Körper eines Patienten eingeführt und aus dem Körper herausgezogen wird und wobei die Sonde einen Spulenkörper (2) umfasst, auf dem eine HF-Spule (3) angebracht ist, <b><u>dadurch gekennzeichnet</u>, dass</b> der Spulenkörper (2) auch mindestens einen Wandler oder Sensor (6, 7, 8, 9) in einem festen Verhältnis zu der genannten HF-Spule trägt, um das Ziel der Energie im Zusammenhang mit einem Eingriff sowohl hinsichtlich der Position als auch in Hinblick auf die Stärke zu steuern.</claim-text></claim>
<claim id="c-de-01-0002" num="0002">
<claim-text>Sonde (1) nach Anspruch 1, <b><u>dadurch gekennzeichnet</u>, dass</b> der Spulenkörper (2) mindestens zwei Wandler oder Sensoren (6, 7, 8, 9) in einem festen Verhältnis zu der genannten HF-Spule trägt, um das Ziel der Energie im Zusammenhang mit einem Eingriff sowohl hinsichtlich der Position als auch in Hinblick auf die Stärke zu steuern.</claim-text></claim>
<claim id="c-de-01-0003" num="0003">
<claim-text>Sonde (1) nach Anspruch 1 oder 2 zur Verwendung bei interventioneller Ultraschall-Ablation, <b><u>dadurch gekennzeichnet</u>, dass</b> mindestens einer der Wandler oder Sensoren (6, 7, 8, 9) ein piezoelektrischer Wandler ist.</claim-text></claim>
<claim id="c-de-01-0004" num="0004">
<claim-text>Sonde (1) nach Anspruch 3, <b><u>dadurch gekennzeichnet</u>, dass</b> der piezoelektrische Wandler ein PLZT-Wandler ist.</claim-text></claim>
<claim id="c-de-01-0005" num="0005">
<claim-text>Sonde (1) nach Anspruch 1 oder 2, <b><u>dadurch gekennzeichnet</u>, dass</b> mindestens einer der Sensoren (6, 7, 8, 9) ein Infrarotsensor ist.</claim-text></claim>
<claim id="c-de-01-0006" num="0006">
<claim-text>Verfahren zum Kalibrieren eines extern erzeugten Energiebündels zur Verwendung bei einem Eingriff am Patienten, das die folgenden Schritte umfasst: In den Patienten eine Sonde (1) nach Anspruch 1 einführen, die einen Spulenkörper (2) und eine auf dem Spulenkörper (2) angebrachte HF-Spule (3) zur Verwendung mit einem Gerät zur<!-- EPO <DP n="10"> --> Bildgebung mittels Magnetresonanz umfasst; das Strahlenbündel mit einer Leistung, bei der eine Schädigung des Gewebes nicht möglich ist, auf mindestens einen Wandler oder Sensor (6, 7, 8, 9) in der Sonde (1) lenken; und die tatsächliche Position des Wandlers abgeleitet von dem Gerät zur Bildgebung mittels Magnetresonanz mit der angegebenen Position abgeleitet von dem Steuergerät für das extern erzeugte Energiebündel vergleichen.</claim-text></claim>
<claim id="c-de-01-0007" num="0007">
<claim-text>Verfahren nach Anspruch 6, <b><u>dadurch gekennzeichnet</u>, dass</b> der Wandler oder Sensor (6, 7, 8, 9) auf Ultraschallschwingungen reagiert.</claim-text></claim>
</claims><!-- EPO <DP n="11"> -->
<claims id="claims03" lang="fr">
<claim id="c-fr-01-0001" num="0001">
<claim-text>Sonde (1) à utiliser avec un appareil d'imagerie par résonance magnétique, laquelle sonde est conçue pour être introduite dans et retirée d'un patient et qui comprend un noyau (2) sur lequel une bobine rf (3) est montée, <b>caractérisée en ce que</b> le noyau (2) supporte également au moins un transducteur ou un capteur (6, 7, 8, 9) suivant une relation fixe à ladite bobine rf afin de commander la cible d'énergie se rapportant à une procédure interventionnelle à la fois en ce qui concerne la position et l'intensité.</claim-text></claim>
<claim id="c-fr-01-0002" num="0002">
<claim-text>Sonde (1) suivant la revendication 1, <b>caractérisée en ce que</b> le noyau (2) supporte au moins deux transducteurs ou capteurs (6, 7, 8, 9) suivant une relation fixe à ladite bobine rf afin de commander la cible d'énergie se rapportant à une procédure interventionnelle à la fois en ce qui concerne la position et l'intensité.</claim-text></claim>
<claim id="c-fr-01-0003" num="0003">
<claim-text>Sonde (1) suivant la revendication 1 ou 2 à utiliser avec une ablation par ultrasons interventionnelle, <b>caractérisée en ce qu'</b>au moins un des transducteurs ou capteurs (6, 7, 8, 9) est un transducteur piézoélectrique.</claim-text></claim>
<claim id="c-fr-01-0004" num="0004">
<claim-text>Sonde (1) suivant la revendication 3, <b>caractérisée en ce que</b> le transducteur piézoélectrique est un transducteur PLZT.</claim-text></claim>
<claim id="c-fr-01-0005" num="0005">
<claim-text>Sonde (1) suivant la revendication 1 ou 2, <b>caractérisée en ce qu'</b>au moins un des capteurs (6, 7, 8, 9) est un capteur infrarouge.</claim-text></claim>
<claim id="c-fr-01-0006" num="0006">
<claim-text>Procédé d'étalonnage d'un faisceau généré à l'extérieur d'énergie à utiliser dans une procédure interventionnelle sur un patient, comprenant les étapes d'introduction dans le patient d'une sonde (1) suivant la revendication 1 comprenant un noyau (2) et une bobine rf (3) montée sur le noyau (2) à utiliser avec un appareil d'imagerie par résonance magnétique, le guidage du faisceau à une puissance à laquelle il n'est pas possible d'endommager le tissu à au moins un transducteur ou capteur (6, 7, 8, 9) dans la sonde (1), et la comparaison de la position à cet instant du transducteur dérivée de l'appareil d'imagerie par résonance magnétique à la position indiquée dérivée d'un appareil de commande pour le faisceau généré à l'extérieur d'énergie.</claim-text></claim>
<claim id="c-fr-01-0007" num="0007">
<claim-text>Procédé suivant la revendication 6, <b>caractérisé en ce que</b> le transducteur ou capteur (6, 7, 8, 9) réagit à des vibrations ultrasonores.</claim-text></claim>
</claims><!-- EPO <DP n="12"> -->
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